A discussion of the ethical issues raised by a patient’s request for off-label, prophylactic bariatric surgery to prevent diabetes mellitus type 2 (DM type 2).
Does a surgeon’s complication rate in a randomized controlled trial constitute a “significant new finding” that must be reported to patients during the consent process?
Douglas E. Paull, MD, MS and Paul N. Uhlig, MD, MPA
Risk managers can help patient-subjects and clinician-researchers make informed novel device implantation decisions in the absence of preclinical trial data.
AMA J Ethics. 2020;22(11):E911-918. doi:
10.1001/amajethics.2020.911.